The purpose of this study is to evaluate whether maintenance antiretroviral therapy could be simplified to DTG + FTC dual therapy and/or patient-centered monitoring once virological suppression is achieved. Using a factorial design, the study aims to assess the efficacy of DTG + FTC dual therapy to maintain virological suppression through 48 weeks of follow-up as well as the costs of a patient-centered ART laboratory monitoring.
Name: Switch to DTG + FTC
Description: Switch from standard cART to DTG + FTC dual maintenance therapy.Type: DrugSwitch to DTG+FTC + Patient-centered monitoring Switch to DTG+FTC + Standard monitoring
Name: Patient-centered monitoring
Description: Immunological and safety blood examinations performed only once per year at least one options (decentralised venipuncture and blood tests, delivery of ARV drugs by mail and interview by phone or skype call) for weeks 6, 12 and 36Type: OtherContinuing cART + Patient-centered monitoring Switch to DTG+FTC + Patient-centered monitoring
Description: Proportion of patients maintaining HIV-RNA <100 copies/ml throughout 48 weeks
Measure: Efficacy of DTG-based maintenance therapy (< 100 copies/ml) Time: 48 weeksDescription: Direct costs of the two study arms from the health care system perspective at week 48
Measure: Costs of a patient-centered ART monitoring Time: 48 weeksDescription: Proportion of patients maintaining HIV-RNA <50 copies/ml throughout 48 weeks
Measure: Efficacy of DTG-based maintenance therapy (<50 copies/ml) Time: 48 weeksDescription: Proportion of patients with HIV-RNA < 50 cp/ml at week 48
Measure: Efficacy of DTG-based therapy (<50 copies/ml) by FDA snapshot analysis Time: 48 weeksDescription: defined as the first of the two-confirmed HIV-RNA >100 copies/ml (at least two weeks apart)
Measure: HIV-RNA >100 copies/ml as time to loss of virological response (TLOVR) Time: 48 weeksDescription: from baseline to week 48
Measure: Change in CD4 cell count Time: 48 weeksDescription: from baseline to week 48
Measure: Change in HIV-DNA Time: 48 weeksDescription: from baseline to week 48
Measure: Change in lipidic profile Time: 48 weeksDescription: from baseline to week 48
Measure: Change in glucose profile Time: 48 weeksDescription: from baseline to week 48
Measure: Change in Framingham-calculated cardiovascular risk Time: 48 weeksDescription: from baseline to week 48
Measure: Change in glomerular function rate Time: 48 weeksDescription: throughout week 48
Measure: Proportion of patients with an adverse event Time: 48 weeksDescription: throughout week 48
Measure: Proportion of patients with a severe adverse event Time: 48 weeksDescription: throughout week 48
Measure: Proportion of patients with CNS adverse event Time: 48 weeksDescription: at 2 and 6 week
Measure: Proportion of patients new to DTG with CNS symptoms Time: 6 weeksDescription: from baseline to weeks 12 and 48
Measure: PROQOL questionnaire Time: 48 weeksDescription: from baseline to weeks 24 and 48
Measure: Patient's monitoring satisfaction for pts in the patient-centered monitoring arm Time: 48 weeksDescription: at week 48
Measure: Global satisfaction of the monitoring Time: 48 weeksDescription: Monitoring satisfaction throughout 48 weeks
Measure: Proportion of patients in the patient-centered monitoring arm expressing willingness to change monitoring options Time: 48 weeksDescription: at week 48
Measure: Patient's treatment satisfaction at week 48 Time: 48 weeksDescription: ART decided to be used in the post study period
Measure: ARV treatment in the post study Time: 48 weeksDescription: at week 48
Measure: Study satisfaction Time: 48 weeksDescription: at week 48
Measure: Cost-effectiveness of study arms Time: 48 weeksDescription: from baseline to week 48
Measure: Change in patient weight Time: 48 weeksDescription: Patient adherence to treatment throughout 48 weeks of follow-up
Measure: Adherence questions Time: 48 weeksDescription: performed outside trial scheduled throughout 48 weeks
Measure: Number of study-related extra clinical visits Time: 48 weeksAllocation: Randomized
Factorial Assignment
There is one SNP
Note: patients with documented genotype(s) presenting only a M184V mutation remain eligible; 3. Creatinine clearance < 50ml/min; 4. ASAT or ALAT >2.5x upper limit of the norm; 5. Known hypersensitivity, intolerance or allergy to DTG or FTC; 6. Known or suspected non-adherence (defined as <80% adherence, i.e. missed doses > 1x/week) to current treatment in the last 6 months; 7. Concomitant use of drugs that decrease DTG blood concentrations including carbamazepine, oxcarbamazepine, phenytoin, phenobarbital, St John's wort and rifampicin; 8. Women who are pregnant or breast-feeding; 9. a. Presence of any INSTI-resistance. --- M184V ---